Growing wiser with age: Results from the ACCELERATE Fostering Age Inclusive Research Group clinical trial survey.
Authors: Max Williamson, Christopher Copland, Maud Toulmonde, Carole License, Evgenia Mengou, Christina Bucci-Rechtweg, Gianluca Rossato, Martin Elliott, Mark Kieran, Stergios Zacharoulis, Solange Corriol-Rohou, Lynley V. Marshall, Nathalie Gaspar
Journal: Journal of Clinical Oncology (2023)

e13596 Background: Adolescent and Young Adult (AYA) cancer patients are disproportionately excluded from clinical trials because of trial age limits that prevent access across the paediatric and adult oncology divide. Working under ACCELERATE, the international collaborative working to improve paediatric cancer drug design and regulation, the Fostering Age Inclusive Research (FAIR) group's aim is to reduce this inequality in access. Here, we report an international survey of AYA oncology professionals, and identify key barriers to age-inclusive participation in clinical trials. Methods: An online survey was created by ACCELERATE-FAIR trials working group members, and subsequently distributed to academic and industry professionals involved in AYA oncology through international networks including the ACCELERATE multi-stakeholder platform, ITCC, and cancer-specific research groups. Demographic factors were recorded, and participants were asked to consider whether listed potential barriers to AYA inclusion are ‘thought’ (presumed/expected) or ‘real’ in practice. Responses were recorded using in-built survey software. Results: The 124 respondents were from Europe (75%), America (22%; North America, Brazil), Algeria, India and Australia. 66 respondents (53%) had participated in opening an ‘adult’ phase I/II which permitted inclusion of adolescents ( &lt; 18 years old), and 63 (51%) had opened a ‘paediatric’ phase I/II trial that included adult cancer patients. Key ‘thought’ barriers to AYA inclusion in early phase (I/II) adult oncology trials largely mirrored ‘real’ barriers, such as “Limited incidence of the disease in adolescents (ages 12 to 17)” and “Trials approved in certain institutions or countries only for 18 years old and above”. A key ‘real’ barrier to the inclusion of AYA patients was “Reluctance from medical oncologists”, identified by 21 responders. Important disparities in the ‘thought’ and ‘real’ barriers to AYA enrolment were also highlighted; “No appropriate adult oncology network” was identified by 2 respondents as a ‘thought’ barrier, and by 13 as a ‘real’ barrier. Importantly, only 35% of respondents were aware of the FDA’s guidance on the inclusion of 12-17 year old patients in adult early-phase trials. Conclusions: This international drug development multi-stakeholder survey highlighted key barriers to clinical trial access in AYA oncology. Whilst more than half of respondents reported being involved in trials which were AYA inclusive, there were clear disparities in understanding the ‘thought’ and ‘real’ barriers to trial entry. Key issues included a lack of medical oncologists responding to this survey. Whilst the issues surrounding AYA inclusion in clinical trials remain, we illustrate key goals for future improvement such as improving understanding around FDA guidance in this area and collaborating further with medical oncologists.